prenate elite
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page 1 of 3 PRENATE ELIT E - vitamin a, ascorbic acid, cholecalciferol, alpha-tocopherol , thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cyanocobalamin, biotin, pantothenic acid, calcium carbonate, ferrous fumarate, iodine, magnesium, zinc and copper tablet, film coated Shionogi Pharma, Inc. DESCRIPTION PRENATE ELITE ® is a white oval oil- and water-soluble multivitamin/mul timineral film-coate d tablet debossed with "PN" on one side. Supplement Facts Serving Size 1 Tablet Amount Per Serving % DV % DV for Pregnant and Lactating Women Vitamin A (100% as Beta-Carotene) 2500 IU 50 % 31 % Vitamin C 80 mg 133 % 133 % Vitamin D 3 400 IU 100 % 100 % Vitamin E 10 IU 33 % 33 % Thiamin (Vitamin B 1 ) 3 mg 200 % 176 % Riboflavin (Vitamin B 2 ) 3.4 mg 200 % 170 % Niacinamide 20 mg 100 % 100 % Vitamin B 6 20 mg 1000 % 800 % Folate 1 mg 250 % 125 % (L-methylfolate calcium 676 mcg (as Metafolin ® ) molar equivalent to 600 mcg of Folic Acid) (Folic acid, USP 400 mcg) Vitamin B 12 12 mcg 200 % 150 % Biotin 300 mcg 100 % 100 % Pantothenic acid 6 mg 60 % 60 % Calcium (calcium carbonate) 120 mg 12 % 9 % Iron (ferrous fumarate) 27 mg 150 % 150 % Iodine 150 mcg 100 % 100 % Magnesium 30 mg 8 % 7 % Zinc 15 mg 100 % 100 % Copper 2 mg 100 % 100 % * Percent Daily Values (DV) are based on a 2,000 calorie diet Other Ingredients: ascorbyl palmitate, calcium sulfate, croscarmellose sodium, dicalcium phosphate, gelatin, hydrogenated soybean oil, hydrogenated vegetable oil, hypromellose, magnesium stearate, maltodextrin, medium chain triglycerides, microcrystalline cellulose, mono and diglycerides, partially hydrogenated soybean oil, polyvinyl alcohol, polyethylene glycol, povidone, silicon dioxide, sodium aluminum silicate, sodium ascorbate, starch, stearic acid, sucrose, talc, titanium dioxide, and water. Metafolin ® (L-methylfolate calcium) is a substantially diastereoisomerically pure source of L-methylfolate containing not more than 1% D-methylfolate. INDICATIONS PRENATE ELITE ® is a multivitamin/multimineral nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. PRENATE ELITE ® can also be beneficial in improving the nutritional status of women prior to conception. CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
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PRENATE ELITE - vitamin a, ascorbic acid, cholecalciferol, alpha-tocopherol, thiamine, riboflavin, niacinamide, pyridoxine,folic acid, cyanocobalamin, biotin, pantothenic acid, calcium carbonate, ferrous fumarate, iodine, magnesium, zinc and copper
tablet, film coatedShionogi Pharma, Inc.
DESCRIPTION
PRENATE ELITE ® is a white oval oil- and water-soluble multivitamin/multimineral film-coated tablet debossed with "PN" on oneside.
Supplement Facts
Serving Size 1 Tablet
Amount Per Serving % DV % DV for Pregnant
and Lactating Women Vitamin A
(100% as Beta-Carotene)2500 IU 50 % 31 %
Vitamin C 80 mg 133 % 133 %
Vitamin D 3 400 IU 100 % 100 %
Vitamin E 10 IU 33 % 33 %
Thiamin (Vitamin B 1) 3 mg 200 % 176 %
Riboflavin (Vitamin B 2) 3.4 mg 200 % 170 %
Niacinamide 20 mg 100 % 100 %
Vitamin B 6 20 mg 1000 % 800 %
Folate 1 mg 250 % 125 %
(L-methylfolate calcium 676 mcg (as Metafolin ®)molar equivalent to 600 mcg of Folic Acid)
(Folic acid, USP 400 mcg)Vitamin B 12 12 mcg 200 % 150 %
Biotin 300 mcg 100 % 100 %
Pantothenic acid 6 mg 60 % 60 %
Calcium (calcium carbonate) 120 mg 12 % 9 %
Iron (ferrous fumarate) 27 mg 150 % 150 %
Iodine 150 mcg 100 % 100 %Magnesium 30 mg 8 % 7 %
Zinc 15 mg 100 % 100 %
Copper 2 mg 100 % 100 %
* Percent Daily Values (DV) are based on a 2,000 calorie diet
Other Ingredients : ascorbyl palmitate, calcium sulfate, croscarmellose sodium, dicalcium phosphate, gelatin, hydrogenated soybeanoil, hydrogenated vegetable oil, hypromellose, magnesium stearate, maltodextrin, medium chain triglycerides, microcrystallinecellulose, mono and diglycerides, partially hydrogenated soybean oil, polyvinyl alcohol, polyethylene glycol, povidone, silicondioxide, sodium aluminum silicate, sodium ascorbate, starch, stearic acid, sucrose, talc, titanium dioxide, and water.
Metafolin ® (L-methylfolate calcium) is a substantially diastereoisomerically pure source of L-methylfolate containing not more than
1% D-methylfolate.INDICATIONS
PRENATE ELITE ® is a multivitamin/multimineral nutritional supplement indicated for use in improving the nutritional status of
women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. PRENATE ELITE ® can also bebeneficial in improving the nutritional status of women prior to conception.
CONTRAINDICATIONSThis product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
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WARNING Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this productout of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
PRECAUTIONSFolic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 isdeficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur whileneurological manifestations progress.
ADVERSE REACTIONSAllergic sensitization has been reported following both oral and parenteral administration of folic acid.
DOSAGE AND ADMINISTRATIONOne tablet daily or as directed by a physician.
HOW SUPPLIEDChild-resistant bottles of 90 tablets – NDC 59630-416-90KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].
U.S. Patents #5,997,915; #6,011,040; #6,254,904; #6,441,168; #6,451,360; #6,673,381; #6,808,725
Prenate Elite ® is a registered trademark of Shionogi Pharma, Inc. Metafolin ® is a registeredtrademark of Merck KGaA, Darmstadt, Germany.©2010 Shionogi Pharma, Inc. Atlanta, GA.All rights reserved.Manufactured for:SHIONOGI PHARMA, INC.Atlanta, GA 30328Manufactured by:Pharmetics, Inc.Laval, Quebec H7L 3H7Made in CanadaTo report a serious adverse event or obtain product information,
contact 1-800-849-9707 ext. 1454PNI-PI-3Rev. 02/10
PRINCIPAL DISPLAY PANEL - 90 TABLETS BOTTLE LABELNDC 59630-416-90
Prenate Elite ®PRENATAL VITAMINS—FILM-COATED TABLETSWith
META FOLIN ®
90 TabletsRx OnlyManufactured for:SHIONOGI PHARMA, INC.Atlanta, GA 30328Manufactured by:Pharmetics Inc.Laval, Quebec H7L 3H7Made in CanadaPNI-TL-2Rev. 02/108633-1
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